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Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction:

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ClinicalTrials.gov Identifier: NCT03497780
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
Peking University Health Science Center
Information provided by (Responsible Party):
Tristan Maerz, University of Michigan

Brief Summary:
The proposed study will establish novel relationships between intra-articular mesenchymal stem cell (MSC) recruitment, synovial inflammation, biomarkers of cartilage degeneration and joint inflammation, clinical patient factors, and downstream alterations in cartilage composition and morphology to provide novel insights into the pathoetiology of post-traumatic osteoarthritis (PTOA) after ACL injury and reconstruction. The study aims to enroll N=38 total patients with primary, isolated rupture to their anterior cruciate ligament (ACL), who have agreed to participate in the study and who will undergo primary surgical reconstruction by an orthopaedic physician at our two sites. Patients will undergo baseline magnetic resonance imaging (MRI), baseline clinical evaluation, and undergo a baseline blood draw. Subsequent imaging and clinical evaluations will be longitudinally performed at several postoperative timepoints up to 12 months postoperatively.

Condition or disease Intervention/treatment
ACL - Anterior Cruciate Ligament Rupture ACL Injury Healthy Procedure: Anterior cruciate ligament reconstruction

Detailed Description:

Overall Study Design: This is a prospective, longitudinal cohort study of patients undergoing primary ACL reconstruction following ACL rupture. Surgical treatment and treatment timelines do not deviate from the national and international standards of care. Enrolled patients for study participation will undergo assessments involving blood, urine, and synovial fluid collection, clinical evaluation involving questionnaires and joint laxity testing, and MRI analysis.

Patient Selection and Enrollment: The participating physicians at each site will identify potential subjects from their clinics' patients according to the inclusion/exclusion criteria listed below. Based on surgical volumes at both sites, patients generally undergo ACL reconstruction 8-12 weeks after initial screening. In the preoperative timeframe, all patients will undergo standard physical therapy to address pain, swelling, and motion deficits, as is standard of care at both institutions. Arthroscopic ACL reconstruction will be performed by Dr. Bedi at the University of Michigan, by Professor Ao at Peking University, and by 5 additional surgeons at Peking University. All surgeons will utilize a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft.


Study Type : Observational
Estimated Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction: A Correlational Study of Synovial Inflammation, Functional Imaging, Clinical Outcomes, and Cartilage Biomarkers
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ACL Tear
Patients with ACL tears
Procedure: Anterior cruciate ligament reconstruction
Primary surgical reconstruction of the rupture anterior cruciate ligament

Healthy Subjects
Healthy subjects



Primary Outcome Measures :
  1. Change in Articular cartilage surface roughness [ Time Frame: Baseline (preop), 12 months ]
    One-year change in articular cartilage surface roughness based on quantitative morphological assessment with 3D MRI.

  2. Change in Serum Cartilage Oligomeric Matrix Protein (COMP) concentration [ Time Frame: Baseline (preop), 12 months ]
    One-year change in the serum concentration of COMP, a biomarker of articular cartilage degeneration.

  3. Change in International Knee Documentation Committee (IKDC) score [ Time Frame: Baseline (preop), 12 months ]
    One year change in IKDC, a patient-reported outcome measure specific to knee injuries.


Secondary Outcome Measures :
  1. Change in quantitative T2 mapping and T1rho mapping relaxation times from MRI. [ Time Frame: Baseline (preop), 12 months ]
  2. Change in concentration of biomarkers of inflammation and cartilage metabolism. [ Time Frame: Baseline (preop), 12 months ]
  3. Change in patient-reported outcome measures [ Time Frame: Baseline (preop), 12 months ]
  4. Change in knee laxity [ Time Frame: Baseline (preop), 12 months ]
    Knee laxity will be measured with KT-2000 testing


Biospecimen Retention:   Samples Without DNA
Serum and plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

Inclusion Criteria:

  • Isolated, traumatic primary anterior cruciate ligament rupture requiring surgical reconstruction
  • Surgical reconstruction performed using a single-bundle technique utilizing an autograft
  • No history of ipsilateral traumatic knee injury or fracture
  • No evidence of Posterior Cruciate Ligament injury or more than grade 1 injury to the Medial or Lateral Collateral Ligament

Exclusion Criteria:

  • Body Mass Index < 18.5 or >35 - Injury occurred longer than 4 weeks before enrollment
  • Intra-articular steroid injection within 3 months of injury
  • Chondral defects greater than 3 cm2 or Outerbridge grade II or higher lesions
  • Pregnant women as they are not eligible for surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497780


Contacts
Contact: Elizabeth Enselman, ATC 734-615-0768 esiblisk@med.umich.edu
Contact: Jaimee Gauthier, BA 734-647-0050 jaimeeg@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Elizabeth Enselman, ATC    734-615-0768    esiblisk@med.umich.edu   
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Liz Enselman, MEd, ATC    734-615-0768    esibilsk@med.umich.edu   
Sub-Investigator: Asheesh Bedi, MD         
Sub-Investigator: Yingfang Ao, MD         
Sponsors and Collaborators
University of Michigan
Peking University Health Science Center

Responsible Party: Tristan Maerz, Research Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT03497780     History of Changes
Other Study ID Numbers: HUM00137279
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Tristan Maerz, University of Michigan:
Healthy Volunteers
ACL (Anterior Cruciate Ligament) tear

Additional relevant MeSH terms:
Wounds and Injuries
Rupture
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries